Pharmaceutical companies must comply with many laws, standards, and rules of different source and type.

Skytechnology supports Customers to use computerized systems in a compliant way, thanks to the expertise in product/process compliance and in product development.

Skytechnology offers a whole set of services:


  • Validation of computerized systems including
    • Acquisition of Customer’s SOPs from the QA Officer regarding computer validation, change control, security and eventually the Validation Master Plan
    • Acquisition of department and system relevant SOPs from System Owner
    • Preparation of Validation Plan
    • Definition of a Risk Assessment
    • Identify of user requirements to define the intended use
    • Life cycle control in case of developed systems and performance of Design Qualification
    • Preparation of SOPs relevant to use, management, security and change control relevant to the system under validation
    • Training to users about SOPs
    • Definition of Qualification Protocols with relevant traceability matrices
    • Test execution and issue of the relevant Qualification Reports
    • Management of non-conformances in accordance to Customer’s SOP.


  • Periodic review of validated computerized sytems to ensure that computerized systems are still validated in accordance with Customer’s SOP or a with ad hoc SOP written by Skytechnology


  • Quality management services:
    • Quality system maintenance with preparation and update of SOPs and instructions
    • Support to incoming audits and audits to supplier
    • Support to the management of CAPA
    • Management of complaints according to 21 CFR requirements


  • Training made according to customer needs. Training subjects include: 21 CFR Part 11, Annex 11, Computer Validation.

Compliance for Pharma flyer